Lumbo-Sacral Flexion Orthosis
FDA 510(k) K811494 · Surgical Appliance Industries, Inc.
510(k) numberK811494
Submission
- Device name
- Lumbo-Sacral Flexion Orthosis
- Applicant
- Surgical Appliance Industries, Inc.
Mchenry, IL, US - Received
- May 27, 1981
- Decision date
- June 16, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IPY – Orthosis, Lumbo-Sacral
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3490
- Specialty
- Physical Medicine
Other 510(k)s with product code IPY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K823882 | M-BraceIPY · Traditional | Buckman Consultants | 01/17/1983SE |
| K823823 | Lumbosacral SupportIPY · Traditional | Danek Medical, Inc. | 01/14/1983SE |
| K812422 | Custom Contour Lumbosacral OrthosisIPY · Traditional | Surgical Appliance Industries, Inc. | 09/14/1981SE |
| K812099 | Cash OrthosisIPY · Traditional | David Hendricks, C.P.O. | 08/13/1981SE |
| K810556 | Spinal Extension BraceIPY · Traditional | Orthomedics | 03/13/1981SE |
| K810554 | Lumbar Flexion BraceIPY · Traditional | Orthomedics | 03/13/1981SE |
| K803033 | Crusader Hyperextension BraceIPY · Traditional | Orthomedics | 12/22/1980SE |
| K801712 | Lumbosacral Supports & Thoraco-Lumbo-SacIPY · Traditional | Fred Sammons, Inc. | 08/07/1980SE |
| K792269 | Wright Dow Corning Softgoods W/DowIPY · Traditional | Dow Corning Wright | 02/05/1980SE |
| K791314 | Vertebrace Spinal SupportsIPY · Traditional | Vertebrace, Inc. | 07/30/1979SE |
More from Vertebrace, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K121106 | Truform Ready-To-Wear Compression Arm Sleece Truform Ready-To-Wear Compression GauntletDWL · Traditional | 04/27/2012SE |
| K821682 | Truncal OrthosisIQE · Traditional | 06/24/1982SE |
| K813416 | External Breast ProsthesisGBI · Traditional | 01/18/1982SE |
| K812423 | Neoprene Knee SupportITQ · Traditional | 09/14/1981SE |
| K812422 | Custom Contour Lumbosacral OrthosisIPY · Traditional | 09/14/1981SE |
| K812401 | Cruciform Anterior Spinal Hyperexten. OIPT · Traditional | 09/14/1981SE |
| K811690 | Ankle-Foot Cast/SplintIQI · Traditional | 06/25/1981SE |
| K811689 | Cylinder Knee Cast/SplintITQ · Traditional | 06/25/1981SE |
Questions and answers
When was Lumbo-Sacral Flexion Orthosis cleared by the FDA?
Lumbo-Sacral Flexion Orthosis (K811494) received a 510(k) decision of Substantially Equivalent on June 16, 1981, 20 days after the submission was received.
What is the product code of K811494?
The FDA product code is IPY – Orthosis, Lumbo-Sacral, a Class I (low risk) device regulated under 21 CFR 890.3490.